510(k) K213633

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler by Ethicon Endo-Surgery, LLC — Product Code GAG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 8, 2022
Date Received: November 17, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stapler, Surgical
Device Class: Class II
Regulation Number: 878.4740
Review Panel: SU
Submission Type

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Other clearances by Ethicon Endo-Surgery, LLC

K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapl (December 17, 2025)
K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (May 14, 2025)
K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapl (February 25, 2025)
K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (October 28, 2024)
K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved (April 13, 2023)
K223760 — ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELO (March 15, 2023)
K221790 — HARMONIC 700 Shears (February 28, 2023)
K221343 — ECHELON ENDOPATH Staple Line Reinforcement (September 16, 2022)

Other clearances for product code GAG

K251482 — AEON Endoscopic Powered Stapler (July 11, 2025)
K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (March 10, 2025)
K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapte (November 1, 2024)
K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
K231934 — GIA Stapler with Tri-Staple Technology (October 27, 2023)
K231491 — TA Stapler and Loading Unit with DST Series Technology (August 16, 2023)
K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular S (August 16, 2023)
K221629 — Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) (February 22, 2023)
K970079 — PROXIMATE DISPOSABLE SKIN STAPLER (March 11, 1997)